FDA 510(k) Application Details - K990930

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K990930
Device Name Mesh, Surgical, Polymeric
Applicant SANTERRA MEDICAL TECHNOLOGY, INC.
5451 HILLTOP AVE.
LAKE ELMO, MN 55042-9539 US
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Contact DAVID P LANG
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 03/19/1999
Decision Date 06/17/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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